RISPERIDONE ALTER 6 mg FILM-COATED TABLETS

2. BEFORE TAKING RISPERIDONE ALTER 6 mg

Do not take Risperidone Alter if:

• You are allergic (hypersensitive) to the active substance or any of the other ingredients of Risperidone Alter (listed in section 6 below).

If you are not sure, consult your doctor or pharmacist before taking Risperidone Alter.

Be cautious with Risperidona Alter

Consult your doctor or pharmacist before taking Risperidone if:

• You have any heart problems. Examples include heart rhythm disorders, or if you are prone to low blood pressure or take blood pressure medications. Risperidone may lower your blood pressure. You may need a dose adjustment.
• If you or a family member have a history of blood clots, these medications may be associated with their formation.
• You know of any factors that may make you prone to having a stroke, such as high blood pressure, cardiovascular disease, or problems with the blood vessels in the brain.
• You have Parkinson's disease or dementia.
• You are diabetic.
• You have epilepsy.
• You are male and have ever had a prolonged or painful erection. If you experience this while taking Risperidone, contact your doctor immediately.
• You have problems controlling your body temperature or feel excessive heat.
• You have kidney problems.
• You have liver problems.
• You have an abnormally high level of the hormone prolactin in your blood or if you have a tumor that may be dependent on prolactin.

Consult your doctor immediately if you experience:

• Involuntary rhythmic movements of the tongue, mouth, or face. It may be necessary to discontinue Risperidone.
• Fever, severe muscle stiffness, sweating, or a low level of consciousness (a condition called "neuroleptic malignant syndrome"). You may need immediate medical treatment.

If you are unsure about any of the above, consult your doctor or pharmacist before taking Risperidone Alter.

Risperidone may cause weight gain.

Elderly patients with dementia

In elderly patients with dementia, there is an increased risk of stroke. You should not take risperidone if you have dementia caused by a stroke.

During treatment with Risperidone, you should see your doctor frequently.

If you or your caregiver notice a sudden change in your mental state or the sudden appearance of weakness or numbness in your face, arms, or legs, especially on one side, or confused speech, even if only for a short time, seek medical attention immediately. It may be a sign of a stroke.

Children and adolescents

Other causes of aggressive behavior should be ruled out before starting treatment for behavioral disorders.

If you experience fatigue while taking risperidone, changing the administration schedule may improve your attention difficulties.

Use of other medications

Tell your doctor or pharmacist if you are taking or have recently taken any other medications, including those obtained without a prescription and herbal products.

It is especially important to talk to your doctor or pharmacist if you are taking any of the following:

• Medications that act on your brain, such as those used to calm you down (benzodiazepines) or some pain medications (opioids), allergy medications (some antihistamines), as risperidone may increase their sedative effect.
• Medications that can modify the electrical activity of your heart, such as those used for malaria, heart rhythm problems (such as quinidine), allergies (antihistamines), some antidepressants, or other medications for mental problems.
• Medications that cause a slow heartbeat.
• Medications that cause low potassium levels in the blood (such as some diuretics).
• Medications for high blood pressure. Risperidone may lower blood pressure.
• Medications for Parkinson's disease (such as levodopa).
• Diuretics, which are used for heart problems or to treat swelling in some parts of the body due to fluid retention (such as furosemide or chlorothiazide). Risperidone, taken alone or with furosemide, may increase the risk of stroke or death in elderly patients with dementia.

The following medications may decrease the effect of risperidone:

• Rifampicin (a medication for some infections).
• Carbamazepine, phenytoin (medications for epilepsy).
• Phenobarbital.

If you start or stop taking these medications, you may need a different dose of risperidone.

The following medications may increase the effect of risperidone:

• Quinidine (used for certain heart conditions).
• Antidepressants such as paroxetine, fluoxetine, and tricyclic antidepressants.
• Medications known as beta blockers (used to treat high blood pressure).
• Phenothiazines (e.g., used to treat psychosis or as sedatives).
• Cimetidine, ranitidine (stomach acid blockers).

If you start or stop taking these medications, you may need a different dose of risperidone.

If you are unsure about any of the above, consult your doctor or pharmacist before taking Risperidone Alter.

Taking Risperidone Alter with food and drinks

You can take this medication with or without food. You should avoid consuming alcohol while taking Risperidone.

Pregnancy and breastfeeding

Consult your doctor before taking Risperidone if you are pregnant, trying to become pregnant, or breastfeeding. Your doctor will decide if you can take it.

Newborns of mothers who have used Risperidone in the last trimester of pregnancy may experience the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your newborn experiences any of these symptoms, contact your doctor.

Consult your doctor or pharmacist before taking any medication.

Driving and using machines

Dizziness, fatigue, and vision problems have been observed during treatment with Risperidone. Do not drive or operate tools or machines without consulting your doctor first.

Important information about some of the ingredients of Risperidone Alter 6 mg

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. HOW TO TAKE RISPERIDONE ALTER 6 mg

How much to take

For the treatment of schizophrenia

Adults

• The initial dose is 2 mg per day, which may be increased to 4 mg per day on the second day.
• Your doctor may adjust your dose depending on how you respond to treatment.
• Most people feel better with daily doses of 4 to 6 mg.
• This total daily dose can be divided into one or two doses per day. Your doctor will indicate what is best for you.

Elderly patients

• The initial dose will normally be 0.5 mg, twice a day.
• Later, your doctor may gradually increase the dose to 1 mg - 2 mg, twice a day.
• Your doctor will indicate what is best for you.

Children and adolescents

• Children and adolescents under 18 years of age should not receive treatment with Risperidone for schizophrenia.

For the treatment of mania

Adults

• The initial dose will normally be 2 mg, once a day.
• Later, your doctor may adjust the dose gradually depending on your response to treatment.
• Most people feel better with daily doses of 1 to 6 mg.

Elderly patients

• The initial dose will normally be 0.5 mg, twice a day.
• Later, your doctor may adjust the dose gradually to 1 mg - 2 mg, twice a day, depending on your response to treatment.

Children and adolescents

• Children and adolescents under 18 years of age should not receive treatment with Risperidone for bipolar mania.

For the long-term treatment of aggression in people with Alzheimer's disease

Adults (including elderly patients)

• The initial dose will normally be 0.25 mg, twice a day.
• Later, your doctor may adjust the dose gradually depending on your response to treatment.
• Most people feel better with doses of 0.5 mg, twice a day. Some patients may need 1 mg, twice a day.
• Treatment duration in patients with Alzheimer's disease should not exceed 6 weeks.

For the treatment of behavioral disorders in children and adolescents

The dose will depend on your child's weight:

If they weigh less than 50 kg

• The initial dose will normally be 0.25 mg, once a day.
• The dose may be increased, one day yes and one day no, in increments of 0.25 mg per day.
• The normal maintenance dose is 0.25 mg to 0.75 mg, once a day.

If they weigh 50 kg or more

• The initial dose will normally be 0.5 mg, once a day.
• The dose may be increased, one day yes and one day no, in increments of 0.5 mg per day.
• The normal maintenance dose is 0.5 mg to 1.5 mg, once a day.

Treatment duration in patients with behavioral disorders should not exceed 6 weeks.

Children under 5 years of age should not receive treatment with Risperidone for behavioral disorders.

Patients with liver or kidney problems

Regardless of the disease being treated, all initial and subsequent doses of risperidone should be reduced by half. Dose increases should be made more slowly in these patients.

Risperidone should be used with caution in this group of patients.

How to take Risperidone Alter

Always take Risperidone Alter exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will tell you how much medicine to take and for how long. This will depend on your disease and may vary from person to person. The amount of medicine you should take is explained above in the "How much to take" section.

Risperidone Alter film-coated tablets

• Swallow the medicine with a glass of water.

If you take more Risperidone Alter than you should

• Go to the doctor immediately. Take the medicine package with you. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.
• In case of overdose, you may feel drowsy or tired, have abnormal body movements, problems standing and walking, dizziness due to low blood pressure, or have abnormal heartbeats or seizures.

If you forget to take Risperidone Alter

• If you forget to take a dose, take it as soon as you remember. But if it's almost time for the next dose, skip the missed dose and continue as normal. If you forget two or more doses, contact your doctor.
• Do not take a double dose (two doses at once) to make up for missed doses.

If you stop taking Risperidone Alter

Do not stop taking the treatment unless your doctor tells you to. Symptoms may return. If your doctor decides to stop the treatment, your dose may be gradually decreased over a few days.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Risperidone can cause adverse effects, although not all people suffer from them.

Very frequent: affects more than 1 in 10 people

Frequent: affects between 1 and 10 in 100 people

Infrequent: affects between 1 and 10 in 1000 people

Rare: affects between 1 and 10 in 10,000 people

Very rare: affects less than 1 in 10,000 people

Unknown: the frequency cannot be estimated from the available data

The following side effects may appear:

Very frequent (affects more than 1 in 10 people)

• Parkinsonism. It is a medical term that includes several symptoms. Each individual symptom may occur with less frequency than 1 in 10 people. Parkinsonism includes: increased saliva secretion or very moist mouth, musculoskeletal stiffness, drooling, pain when bending limbs, slower, reduced, or difficult body movements, lack of facial expression, muscle tension, torticollis, muscle stiffness, short and rapid steps when walking, dragging feet, and absence of normal arm movements, persistent blinking as a response to forehead tapping (an abnormal reflex).
• Headache, difficulty staying or remaining asleep.

Frequent (affects between 1 and 10 in 100 people):

• Drowsiness, fatigue, tiredness, inability to remain still, irritability, anxiety, somnolence, dizziness, attention problems, feeling of exhaustion, sleep disturbance
• Vomiting, diarrhea, constipation, nausea, increased appetite, abdominal pain or discomfort, sore throat, dry mouth
• Weight gain, increased body temperature, decreased appetite
• Difficulty breathing, lung infection (pneumonia), flu, respiratory tract infection, blurred vision, nasal congestion, nasal bleeding, cough
• Urinary tract infection, bedwetting
• Muscle cramps, involuntary movements of the face or arms and legs, joint pain, back pain, swelling of arms and legs, pain in arms and legs
• Rash, skin redness
• Fast heartbeat, chest pain
• Increased concentration of prolactin hormone in the blood.

Infrequent (affects between 1 and 10 in 1000 people):

• Excessive water consumption, fecal incontinence, thirst, very hard stools, hoarseness or voice disorder
• Lung infection caused by food passing into the airways, bladder infection, eye redness, sinusitis, viral infection, ear infection, tonsil infection, infection under the skin, eye infection, stomach infection, eye discharge, fungal infection of the nails,
• Anomaly in the electrical conduction of the heart, drop in blood pressure when standing up, decreased blood pressure, feeling of dizziness when changing position, anomaly of heart electrical activity (ECG), abnormal heart rhythm, feeling heartbeats, fast or slow heartbeat
• Urinary incontinence, pain when urinating, frequent urination
• Confusion, attention disorder, low level of consciousness, excessive sleepiness, nervousness, elevated mood (mania), lack of energy and interest
• Increased blood glucose, increased liver enzymes, decreased white blood cell count, decreased hemoglobin or red blood cell count (anemia), increased eosinophil count (special white blood cells), increased creatine phosphokinase, decreased platelet count (blood cells that help stop bleeding)
• Muscle weakness, muscle pain, ear pain, neck pain, joint swelling, abnormal posture, joint stiffness, chest muscle and bone pain, chest discomfort
• Skin injury, skin disorder, skin dryness, intense itching, acne, hair loss, skin inflammation caused by mites, skin discoloration, skin thickening, flushing, reduced skin sensitivity to pain or touch, fatty skin inflammation
• Absence of menstruation, sexual dysfunction, erectile dysfunction, ejaculation disorder, breast secretion, increased breast size in males, decreased sexual desire, irregular menstruation, vaginal discharge
• Fainting, gait disorder, inactivity, reduced appetite with malnutrition and weight loss, feeling of "indisposition", balance disorder, allergy, edema, speech disorder, chills, coordination anomaly
• Painful sensitivity to light, increased blood flow to the eye, eye swelling, dry eyes, increased tearing
• Respiratory tract disorder, pulmonary congestion, lung crackling sounds, respiratory tract congestion, speech problems, difficulty swallowing, cough with sputum, wheezing or whistling sound when breathing, pseudoinfluenza disease, sinusitis
• Absence of response to stimuli, loss of consciousness, sudden swelling of lips and eyes with difficulty breathing, sudden weakness or numbness of face, arms, or legs, especially on one side, or cases of confused speech lasting less than 24 hours (called mini-stroke or stroke), involuntary movements of face, arms, or legs, ringing in the ears, facial edema.

Rare (affects between 1 and 10 in 10,000 people):

• Difficulty reaching orgasm, menstrual disorder
• Dandruff
• Drug allergy, coldness in arms and legs, lip swelling, lip inflammation
• Glaucoma, decreased visual acuity, crust formation on the eyelid edge, eye movement
• Absence of emotions
• Altered consciousness with increased body temperature and muscle spasms, edema throughout the body, drug withdrawal syndrome, decreased body temperature
• Rapid and shallow breathing, respiratory problems during sleep, chronic middle ear infection
• Intestinal obstruction,
• Decreased blood flow to the brain
• Decreased white blood cell count, inadequate secretion of a hormone that controls urine volume
• Muscle fiber rupture and muscle pain (rhabdomyolysis), movement disorder
• Diabetic coma due to uncontrolled diabetes
• Yellowing of the skin and eyes (jaundice)
• Pancreatitis.

Very rare (affects less than 1 in 10,000 people):

• Complications of uncontrolled diabetes, life-threatening

Unknown frequency of adverse effects (the frequency cannot be estimated from the available data)

• Severe allergic reaction leading to difficulty breathing and shock
• Absence of granulocytes (a type of white blood cell that helps fight infections)
• Prolonged and painful erection
• Excessive and dangerous water intake
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), these clots can move through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek medical attention immediately.

Risperidone Long-Acting Injectable

The following adverse effects have been reported with the use of Risperidone Long-Acting Injectable. If you experience any of the following effects, talk to your doctor, even if you are not receiving treatment with long-acting Risperidone injections:

• Intestinal infection
• Abscess under the skin, tingling, pinching, or numbness of the skin, skin inflammation
• Decreased white blood cell count, cells that help protect against bacterial infections
• Depression
• Seizures
• Eye twitching
• Feeling of spinning or oscillation
• Slow heartbeat, increased blood pressure
• Toothache, tongue spasm
• Pain in the buttocks
• Weight loss.

If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

5. Storage of RISPERIDONE ALTER 6 mg

Do not store at a temperature above 30 °C.

Keep out of the reach and sight of children.

Do not use after the expiration date shown on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point (or any other pharmaceutical waste collection system) at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment

6. ADDITIONAL INFORMATION

Composition of Risperidone Alter

The active ingredient is risperidone.

Each film-coated Risperidone Alter tablet contains 6 mg of risperidone.

The other components are:

Core of the tablet:

Lactose monohydrate, pregelatinized starch, microcrystalline cellulose, hydroxypropyl methylcellulose, sodium lauryl sulfate, colloidal silicon dioxide, and magnesium stearate

Coating:

Hydroxypropyl methylcellulose, titanium dioxide, and triacetin.

Appearance of Risperidone Alter and packaging content

The 6 mg risperidone film-coated tablets are oblong and white

They are marketed in packages of 30 or 60 tablets.

Marketing authorization holder and manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid

This prospectus was revised in September 2012

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/